The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK910020 |
| 510k Number | BK910020 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Cobe Laboratories, Inc. 1185 Oak Street Lakewood, CO 80215 |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-20 |
| Decision Date | 1992-11-02 |